Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer

This study is currently recruiting participants.

Verified January 2013 by European Lung Cancer Working Party

Sponsor:

Information provided by (Responsible Party):

European Lung Cancer Working Party

ClinicalTrials.gov Identifier:

NCT00864266

First received: March 16, 2009

Last updated: January 28, 2013

Last verified: January 2013

History of Changes

Purpose

The primary aim of the study is to identify a predictive molecular signature for response to chemotherapy, according to WHO criteria, in patients with non-small cell lung cancer by studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs) by using high throughput techniques.

Condition	Intervention
Non Small Cell Lung Carcinoma	Drug: Chemotherapy

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer : a Prospective Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by European Lung Cancer Working Party:

Primary Outcome Measures:

Response rate [ Time Frame: response will be assessed every 3 cycles of chemotherapy according to WHO criteria ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Survival [ Time Frame: Survival will be dated from the date of treatment ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: Period between the date of treatment and the date of first progression or death ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: period between the day of treatment and the date of first progression in patients with an objective response ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 After obtaining the biopsy, patients will be treated by standard chemotherapy (the regimen has to be in agreement with the ELCWP guidelines, available on the website www.elcwp.org)	Drug: Chemotherapy Standard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histological diagnosis of non-small-cell lung cancer (NSCLC)
Obtention of a biopsy of the tumour according to the procedure defined in the protocol
NSCLC of any stage to be treated by standard conventional first-line chemotherapy, as defined in the ELCWP guidelines (www.elcwp.org)
Presence of at least one assessable lesion
Availability for participating in the detailed follow-up of the protocol
Signed informed consent.
Age above 18 years

Exclusion Criteria:

Patient who was previously treated with chemotherapy for NSCLC or who has any contra-indication precluding the administration of conventional chemotherapy for NSCLC
NSCLC treated by exclusive surgery or radiotherapy
A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864266

Contacts

Contact: Nathalie Leclercq, RN	0032/2/5390496	nathalie.leclercq@bordet.be
Contact: Thierry Berghmans, MD	0032/2/5390496

Locations

Belgium
Department of Pneumology Clinique Saint-Luc	Recruiting
Bouge, Belgium, 5004
Contact: Oswald Van Cutsem, MD
Principal Investigator: Oswald Van Cutsem, MD
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet	Recruiting
Brussels, Belgium, 1000
Contact: Thierry Berghmans, MD 0032/2/5390496
Principal Investigator: Thierry Berghmans, MD
Service de Pneumologie Hôpital Erasme	Recruiting
Brussels, Belgium, 1070
Contact: Paul deVuyst, MD, PhD
Contact: Dimitri Leducq, MD
Principal Investigator: Paul deVuyst, MD
Department of Pneumology Hôpital Saint-Joseph	Recruiting
Gilly, Belgium, 6060
Contact: Benoît Colinet, MD
Principal Investigator: Benoît Colinet, MD
Hôpital Ambroise Paré	Recruiting
Mons, Belgium, 7000
Contact: Stéphane Holbrechts, MD
Sub-Investigator: Patricia Wackenier, MD
Principal Investigator: Stéphane Holbrechts, MD
Department of Pneumology Centre Hospitalier de Mouscron	Recruiting
Mouscron, Belgium, 7700
Contact: Christian Tulippe, MD
Principal Investigator: Christian Tulippe, MD

Sponsors and Collaborators

European Lung Cancer Working Party

Investigators

Study Chair:

Thierry Berghmans, MD

European Lung Cancer Working Party

More Information

Additional Information:

(Click here for more information on the protocol) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	European Lung Cancer Working Party
ClinicalTrials.gov Identifier:	NCT00864266 History of Changes
Other Study ID Numbers:	01082
Study First Received:	March 16, 2009
Last Updated:	January 28, 2013
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by European Lung Cancer Working Party:

Non small cell lung carcinoma
Chemotherapy
Response prediction

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic

Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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